Surgical method for sterilization

ABSTRACT

This invention relates to the design, manufacture, and installation procedures for accomplishing a reversible male sterilization operation through the implanting of tiny, especially designed plastic valve assembly in the tubes of the vas deferens through the use of a special installing device. The plastic valve assembly, the method of manufacture and installation of same, and the special installing apparatus make up this invention.

United States Patent 1191 Rogers June 28, 1974 SURGICAL METHOD FOR STERILIZATION [76] inventor: William P. Rogers, 6312 Senate,

Little Rock, Ark. 72109 [22] Filed: Feb. 10, 1972 211 Appl. No.: 225,253

52] us. 61. 128/1 R, l28/303R 511 1111. c1 A6lb 19/00 [58] Field 01 Search 128/1 R, 303 R, 305, 325, 128/327, 346

[56] References Cited UNITED STATES PATENTS 2,250,605 7/l94l Rubin 128/346 3,704,704 l2/l972 Gonzales l28/lR 3,707,957 l/l973 Buealo l28/l R Primary ExaminerDalton L. Truluck Attorney, Agent, or FirmAllison C. Collard 57 ABSTRACT This invention relates to the design, manufacture, and installation procedures for accomplishing a reversible male sterilization operation through the implanting of tiny, especially designed plastic valve assembly in the tubes of the vas deferens through the use of a special installing device. The plastic valve assembly, the method of manufacture and installation of same, and the special installing apparatus make up this invention.

5 Claims, 21 Drawing Figures PATENTED m4 3'820 528 SHEET 3 [IF 3 1 SURGICAL METHOD FOR STERILIZATION The object of this invention is to provide the means of accomplishing a normally reversible male sterilization operation, for birth control purposes, that can be I readily and easily performed by qualified medical personnel through theuse of the devices and techniques described in this invention.

A further object of this invention is to disclose the technology required to produce the equipment and plastic valves that are used in accomplishing the valve implant operation such that an open or closed condition of the vas deferens, or sperm ducts, may be achieved as desired by the recipient through a relatively simple surgical procedure.

Another object of this invention is to provide the means of achieving a normally reversible male steriliza tion operation while at the same time eliminating much of the possibility of spermatic granuloma and spontaneous recanalization that may be present with most of the commonly used techniques for accomplishing a standard vasectomy.

FIG. 1 is an isometric explodedview of the valve assembly. e

FIG. 2 is a sectional view of the valve, taken on line 2-2 of FIG. 1.

FIG. 3 is a sectional view of the valve taken in the plane of line 3-3 of FIG. 2.

' FIG. 4 is an isometric view of the valve assembly.

FIG. 5 is a sectional view of the valve assembly prior to heat shrinkage, taken perpendicular to line 5-5 of FIG. 4.

FIG. 6 is a fixture contoured to the desired shape of the finished valve.

FIG. 7 is a heated fluid bath with valve assembly and fixture submerged therein.

FIG. 8 is the finished flexible valve assembly.

FIG. 9 is a sectional view of the finished valve assembly, taken perpendicular to line 5-5 of FIG. 4.

FIG. 10 is an isometric view of a rolled spring clip.

FIG. 11 is a sectional view of the rolled spring clip, taken along line 12-12 of FIG. 10.

FIG. 12 is an isometric view of the rolled spring clip, as viewed along line 11-11 of FIG. 10.

FIG. 13 is a planar viewof the unrolled spring clip as viewed along line 1 1-11.

FIG. 14 is an isometric exploded view of the valve assembly with clip, taken with valve assembly installed in the vas deferens and with spring clip partially unrolled.

FIG. 15 is an isometric view of a vee shaped fixture.

FIG. 16 is an isometric view of the vas deferens held in place by a special tool over the vee shaped fixture viewed in FIG. 15.

FIG. 17 is an-isometric view of the valve assembly immediately prior to implantation in the vas deferens.

FIG. 18 is'an isometric view of the valve assembly immediately after implantation in the vas deferens.

FIG. 19 is an isometric view of the valve assembly implanted in the vas deferens with the spring clip view in FIGS. l0, l1, 12, 13, and 14 installed around the vas deferens. I

FIG. 20 is a sectional view of the valve assembly implanted in the vas deferens with spring clip installed, taken along the long axis of the vas deferens, perpendicular to line 20-20 of FIG. 19.

VASECI'OMY VALVES Specifications Y The male sterilization procedure, commonly known as vasectomy, has been performed for many years as a means of positive birth control. This procedure generally involves severing each of the vas deferens tubes in the scrotum and sealing the cut ends so that no sperm may be transmitted through the tubes past the point of incision.

This operation, commonly considered a minor operation and performed under a local anesthetic, is regarded as the most positive means available for male sterilization. This procedure, however, has the serious disadvantage of being largely non-reversible from a practical standpoint. Fertility can and is restored in patients who have had vasectomies, but the operation to reconnect the tubes of the vas deferens is delicate and costly and is successful in only a limited number of cases.

Further, certain complications may arise as a result of vasectornies performed using procedures that are common and accepted by many surgeons. These procedures usually involve incising a section of each vas and tying off the cut ends of the vas deferens tube with ligatures that may fail or cut through the sealed tube as a result of spermatic pressure buildup often experienced on the obstructed end of the proximal tube. This condition results in leakage of sperm causing spermatic granuloma, which is the accumulation of sperm in pools or fistulas in the scrotum that may be painful and require further medical attention. Spermatic granuloma, or sperm leakage, may also lead to another more serious situation that results in a spontaneous recanalization of the divided vas deferens, with attendant restoration of fertility, often unknown to the subject. This situation has been observed wherein the vas epithelium has regenerated and caused a reconnection of the vas by joining the ends of the vas with a thin tubing lined with epithelium. Thus the vasectomy male sterilization operation, as commonly performed, has serious limitations in terms of reversibility and possible complications at a later date.

In spite of the problems mentioned above, the vasectomy is becoming increasingly popular as a birth control measure. Part of the reason for the increasing popularity of the vasectomy can be traced to the efi'orts of various organizations who have recognized the serious problems of overpopulation facing the world and whose efforts are directed toward reducing the birth rate.

With the foregoing in mind it is apparent that a tremendous need exists for a simple and inexpensive method of improving the male sterilization procedure. The invention disclosed and described in this specification provides the equipment and techniques that will permit a vast improvement in the state of the art of male sterilization procedures.

The basic concept of this invention relates to the introduction of a valve device, referred to here as the vasectomy valve, into each tube of the vas deferens. This device is a very small plastic valve of a type commonly known as a ball valve, but which is especially designed and constructed so as to be introduced into the vas deferens tube where it will remain implanted and functional for the life of the recipient under conditions normal to its location in the body. The novelty of this invention involves the method of installing the controllable plastic valve device in the tubes of the vas deferens, the unique processes associated with the manufacture of these tiny devices, the proper selection of materials for the construction of the valve in order to permit it to remain functional yet be compatible with the installing techniques and the conditions of permanent implantation in the human body, and the development of the tools and procedures required to accomplish the implantation of the valves in the vas deferens while reducing the possibility of causing spermatic granuloma or recanalization of the vas deferens. In addition, the novelty of the installing tool and procedure is such as to permit the accomplishment of the reversible vasectomy valve installation or operation with little additional skill or difficulty than is required to perform any of the standard vasectomy procedures that reflect the current state of the art.

It should be noted here that the basic concept of using a valve device implanted in the vas deferens for birth control purposes is recognized as not new or novel and the concept of using a valve for this purpose is not intended to be part of this invention. Rather, this invention is a new development in the state of the art of reversible male sterilization procedures wherein a practical system is developed which involves especially designed devices made of unique materials that possess desirable characteristics and permits the production of semi-flexible valves that are compatible with the special installing tool and installing procedure. Further, the unique design process, and materials used in the invention lends itself to low cost volume manufacture of the valves, which is a very important part of the practicality and usefulness of this invention. Further, no claim is made that the invention will permit a 100% reversibility of the sterile condition achieved by the valve due to the possibility of other complications arising, such as spennatic granuloma of the epididymis or autoantibody response to sperm, which has no relation to the proper operation of the valve in its intended purpose of providing a controllable open or closed passage through the lumen of the vas deferens.

The basic valve device consists of the small ball valve 1 less than one centimeter long, of FIG. 1, having a body 2, of FIG. 1, partially enclosing a ball, 3 of FIGS. l,2,4,5,7,8,9,14,l8, and 20, affixed to a head or extension, 4 of FIGS. l,2,3,4,5,7,8,9,14,l7,18,19,20, and 21, that extends through an opening, 5 of FIGS. 1,4,5, and 8, in the body of the valve and having a slot, 6 of FIGS. l,2,3,4,7,8,14,l7,18 and 19, cut in the flat surface on the top of the head, or extension. The ball contains a hole, 7 of FIGS. l,2,4,5,7,8,9,14, and 20, approximately one half millimeter in diameter extending through the center of the ball and parallel to the slot in the top or head of the valve ball extension. The body of the valve consistsof a semi-flexible tube, 8 of FIG. 8, extending on either side of a slightly enlarged portion, 9 of FIG. 8, in the center that is shaped to contain the ball. The body has a hole, 5 of FIG. 8, at the top of the enlargedportion that is smaller than the diameter of the ball to encase the ball in the socket of the valve body in such a way as to contain it within the valve body yet permit it to be rotated within the valve body by means of the slotted head extending from the valve body. The body is composed of a heat-shrinkable plastic tubing material that has been shrunk around the ball after the ball is inserted into the circular hole, 5 of FIG. 1, in the tube, causing the edge of the hole to fit closely around the neck portion, 10 of FIGS. 2 and 9 of the ball extension, 4 of FIG. 8, protruding from the valve body.

A rolled plastic spring clip, 11 of FIGS. l0,ll,l2,l3,14,19,20, and 21, containing a hole, 12 of FIGS. l0,l2,l3,14,19,20, and 21, designed to fit over the valve ball extension makes up the completed valve assembly. This clip consists of a rolled cylinder of a normal diameter approximately the same as the diameter of the human vas deferens and is designed to physically contain the vas and prevent expansion of the vas within the clip due to internal spermatic pressure. The clip contains a loop, 13 of FIGS. l0,l2,l3,l4,l9, and 21, on one end to fit over the valve extension in order to stabilize the clip in relation to the valve and also to serve as a scar shield to help prevent scar tissue from growing over the top of the valve extension. This clip will be brightly pigmented in order to facilitate the location of the small valve at a future date.

Thus the pierced ball, which comprises the active member of the valve, is tightly enclosed in the socket or enlarged portion of the valve body such that the fitted members will not permit fluid to pass between the surfaces of the ball and the inner valve body. The materials of construction of the valve body, ball and clip must be such as to withstand continuous exposure to body fluids without physical change yet possess a high degree of anti-corrosive and anti-stick properties in order that the ball may be rotated within the valve body to permit an open or closed position of the pierced hole in the ball in relation to the openings of the tubes of the valve body. For this reason the materials of construction of the valve body and ball are selected from the family of compounds known as fluoroplastics which are plastic materials possessing flexibility and unique anti-stick properties as well as almost complete resistance to chemical attack and moisture absorption. These qualities are most important to the proper functioning of a valve of this type designed to be implanted in the body, remain in a stationary position for an indefinite length of time, and yet be easily rotated to a position without difficulty.

The unique manufacturing process required for volume production of the valves will call for a further selection of materials within the family of the fluoroplastic compounds to a material commonly known as tetrafluoroethylene (TFE). This material possesses an almost universal chemical inertness, exhibits outstanding chemical and thermal stability, is self lubricating, flexible, and has the lowest friction coefficient of any known solid material. Further, the material is nonporous and resists contamination and possesses virtually zero moisture absorption, which is most important from a medical and functional standpoint. The unique anti-stick properties of this material also prevent the adherence of human scar tissue to the valve. This is important in preventing scar tissue from forming around the head of the ball and possibly interfering with the operation of the valve when it is called upon to function at a later date, possibly years after the date of implantation. Finally, the TFE material possesses heat shrinkable properties. That is, the material, if subjected to a controlled mechanical stretch during initial production, will return to the pre-stretch shape and size upon application of controlledheat. Thus heat shrinkable TFE tubing, having been expanded to a larger diameter by a controlled mechanical stretching action, will return to the original smaller diameter when heated to proper temperature. This feature is vital to the economical mass production of the device as will be explained in the following detailed description of the process for producing the TFE vasectomy valve.

The manufacture of the vasectomy valve isaccomplished by forming the ball and extension component by the commonly known process of form grinding. The blank ball is then placed in a fixture and the hole drilled through the ball with a sensitive drill and the screwdriver slot cut across the top of the extension, and parallel with the hole in the ball, with a thin abrasive grinder wheel. The valve body is produced from short sections of expanded heat-shrinkable TFE tubing, 2 of FIG. 1, that has been expanded from a normal diameter of approximately that of the inside diameter of the human vas deferens to a diameter one-third to double the original unstretched diameter. A circular hole, 5 of FIGS. 1,4, and 5, of approximately the same diameter of the valve ball is cut in the center of one wall of the section of expanded TFE tubing with a circular knife in order that the ball component may be inserted in the tubing.

The ball component 3 of FIGS. 2,4, and 7, is inserted in the hole in the tubing, affixed to a fixture, 14 of FIGS. 6 and 7, contoured to the desired shape of the finished valve assembly and the assembly with fixture submerged, FIG. 7, in a heated fluid, normally a neutral oil, that is held at controlled temperature of 621 degrees F. The length of time and temperature required to achieve the desired shrink of the tubing may vary slightly for tubing obtained from various suppliers and the optimum conditions of time and temperature for full shrink are readily available from the tubing manufacturers and technical literature.

During the heating process the tubing will shrink around the TFE ball and encase it tightly in a socket that will conform exactly to the surface of the ball and form a fluid-tight seal between the surface of the ball and the inner wall of the tube. Since TFE has an extremely high melting point, considerably'higher than the shrinking temperature, there will be no fusion of the plastic material of the tube and the ball and the ball component may be rotated in a horizontal plane within the formed socket as desired by means of the screwdriver slot in the head of the ball extension. This nonfusing characteristic of the TFE material along with its superior anti-stick properties permit the use of this process as would no other material.

It should be pointed out that there is a tendency for the ball to be forced upward through the hole during the shrinking process by the pressure of the shrinking tube and the contoured fixture designed to hold the ball firmly in place through mild pressure on the valve extension head is used to avoid this problem.

The rolled TFE spring clip may be produced by thermoforming or extrusion and the loop formed by punching the flattened material with a punch of a diameter only slightly larger than the head of the ball extension. When the clip is released to return to its normally cylindrical shape the loop in the clip will present an elliptical shape, when viewed from directly above, 15 of FIG. 12,

or below, which will not pass over the head of the valve extension. Thus only by again flattening, FIG. 13, the end of the clip containing the hole may it be placed, FIG; 14, over the valve extension, FIG. 19, and, once released to assume normal shape, FIG. 19, below the maximum diameter portion of the valve extension, will be secured to the valve extension so that it cannot slip off over the top of said extension.

The dimensions of the valve can be varied, using ball components of various sizes and various diameters of tubing, to produce a range of sizes of valves to fit the range of sizes of the vas deferens in which the valves are to be-installed.

The installation of the vasectomy valve in the tubes of the vas deferens may be accomplished in several ways. The most obvious way is to simply cut the vas deferens tube and insert the ends of the valves into the severed vas tube ends, reconnecting the tube with the valve in position where flow through the vas may be interrupted by changing the position of the valve ball. This method, however, has the disadvantage of requiring sutures connecting the ends of the vas and drawing them together to prevent them from slipping off the ends of the valve body. This adds to the difliculty of the procedure although this method does permit the use of a larger and easier to manufacture ball valve. However, there is some question regarding encising the vas in this manner in that this may permanently interfere with the manner in which the vas propels the sperm along the vas duct. Thus this method is not recommended as a procedure for installing the vasectomy valve.

A second method of installation requires a special tool which holds the vas clamped flat in a special vee shaped fixture while a fixed-penetration hinged cutting tool is employed to pierce the clamped tube and slit it a fixed length as determined by the travel of the sliding knife affixed to the tool, the distance being slightly shorter than the overall length of the vasectomy valve. The valve is then inserted with special instrument by inserting one end of the valve into the slit, sliding it into the vas as far as it will go and then lowering the other end of the valve into the slit. The valve is then slid in the reverse direction causing the opposite end of the valve to enter the opposite opening of the vas, until the valve head is centered in the slit. Since the length of the slit is less than the overall length of the valve, each end of the valve will be extended into an unslit portion of the vas deferens. It is most important that the tube extend past the ends of the slit in order to avoid the possibility of scar tissue forming to block the vas tube. After the valve is positioned, sutures or small clamps must be used to close the edges of the slit tightly around the valve body in order to prevent sperm leakage or-shifting of the valve. This suturing or clamping must be done across the opening of the slit as any heavy pressure around the vas could cause atrophy of the vas. The suturing or clamping required causes this method to also be more difficult than a standard vasectomy even though the special tool makes it much easier to hold and slit the tube to the prescribed length. Further, this suturing or clamping, along with the attendant skill required and the increased danger of hemorrhage, causes this method to also be not recommended as a means for installing the vasectomy valve.

A third method, claimed as unique and novel and requiring the use of the flexible TFE valve is recommended as being the easiest to accomplish while at the same time causing the least trauma to the vas and presenting the least possibility of hemorrhage, spermatic granuloma, or recanalization. This method is as follows: a special tube slitting tool similar to the one described in the second method is used to slit the vas except that the slit 17 generated is much shorter. Thus, in FIGS. 16 and 17 it is seen that slit 17 is only a few millimeters longer than the diameter of the TFE valve ball housing. The base of the -vee shaped tool, 18 of FIGS. 15,16,17, & 18, used in this procedure is constructed such that it may then be folded upward at the center, thus elevating the slit portion of the vas over an inverted V-shaped holding device, FIGS. 15, 16,17, and 18. This doubling of the vas causes the slit portion 17 to stretch, as seen in FIG. 17, and expose the openings of the uncut vas extending downward along each side of the fixture. The vasectomy valve is then installed by means of spreader 18A of FIG. 17, the edges of the slit and holding the valve with the flexible ends folded downward in a clamp, 16 of FIG. 17, so as to enter the openings of the vas tube simultaneously. The valve ends are extended-into the vas until the valve ball housing rests in the open slit in the vas. The tool, of FIGS. 16, 17, and 18, is then released to return the vas to the level position causing the slit in the vas to tighten around the valve body extension and presenting only the amount of opening in the vas necessary for the ball head or extension to protrude through the vas tube. The need for ligatures or clamps to hold the slit closed in this method and the possibility of tube trauma or leakage is reduced due to the extra length of the valve ends extending beyond the edge of slit and into the unslit portions of the vas.

It has been observed that the proximal tube of the vas often undergoes an enlargement after the tube is closed due to the pressure generated by the continued production of sperm in the testes. As a precaution to prevent the vas tube from distending around the tube of the valve and allowing sperm to go around the valve, the small rolled section of semi-rigid fluoroplastic tubing, 11 of FIGS. 10,1 1,12,13, and 14, is opened, as seen in FIG. 14, and wrapped around the proximal vas beginning at the head of the valve and extending several millimeters beyond the end of the valve. This material is pigmented with a bright color in order to assist in locating the valve at a later date, and will possess a loop, 13 of FIGS. 10,12,13,l4,20, and 21, to fit over the valve extension to prevent movement and to act as a shield against scar tissue forming over the top of the valve extension.

Thus the rolled cylinder of plastic, overlapping somewhat like a plastic ring booklet binding, 19 of FIG. 11, will provide a mild continuous pressure over the surface of the tube of the vas in the area where internal ex pansion of the vas tube due to spermatic pressure could result in sperm leakage around the valve. The plastic cylinder is so designated as to prevent clamping the vas so tightly that the blood supply to the vas would be compromised. This characteristic is necessary to prevent possible ischemia and subsequent degeneration of the vas deferens. The plastic cylinder or sleeve will thus maintain the normal size of the vas on the proximal side of the valve over the point where the end of the valve rests, even though the vas area below and not restricted by the sleeve may experience expansion due to spermatic pressure.

The vasectomy valve will normally be installed in the closed or off position and this condition is so indicated by the position of the screwdriver slot on the top of the valve. A position of the slot perpendicular to the direction of flow through the valve indicates the hole is also in a perpendicular, or closed, position, FIG. 20. To reverse the procedure and restore normal fertility a second small incision is made in the scrotum and the valve ball is rotated by means of inserting and turning a small screwdriver placed in the slot on top of the valve until the slot is in alignment with the direction of flow through the vas deferens. This aligns the hole in the ball with the open tube of the vas, permitting a free passage of sperm through the tube of the vas deferens. Normal fertility should be restored after the valve is changed from a closed to an open position, providing the testicles return to normal sperm production and there is no leakage between the testes and the valve.

I claim:

1. A method for inserting a flexible male sterilization valve in the vas deferens comprising the steps of:

slitting the vas;

inserting an inverted V-shaped tool under the vas;

elevating the vas on the tool so as to stretch the vas and open the slit;

exposing the uncut side portions of the vas extending downward along each side of the tool;

clamping the uncut sides of the vas against their respective tool sides;

folding the flexible valve passageways downward so as to accord with the downward sloping sides of the tool;

spreading the slit sides of the vas apart;

inserting the valve in the opened and spread vas so that the valve ends fit into their respective vas sides;

releasing the slit vas sides so as to close same;

securing the closed vas sides about the inserted valve;

releasing the clamping tool holding the vas sides against the tool sides; and

restoring the vas to the level position.

2. The method as in claim 1 wherein the step of folding the flexible valve passageways downward includes holding the valve ends in the downward position by means of a holding tool.

3. The method as in claim 1 wherein the step of inserting the vas valve includes turning the valve to the off position just prior to said step of inserting the valve.

of securing comprises suturing up the closed vas sides. 

1. A method for inserting a flexible male sterilization valve in the vas deferens comprising the steps of: slitting the vas; inserting an inverted V-shaped tool under the vas; elevating the vas on the tool so as to stretch the vas and open the slit; exposing the uncut side portions of the vas extending downward along each side of the tool; clamping the uncut sides of the vas against their respective tool sides; folding the flexible valve passageways downward so as to accord with the downward sloping sides of the tool; spreading the slit sides of the vas apart; inserting the valve in the opened and spread vas so that the valve ends fit into their respective vas sides; releasing the slit vas sides so as to close same; securing the closed vas sides about the inserted valve; releasing the clamping tool holding the vas sides against the tool sides; and restoring the vas to the level position.
 2. The method as in claim 1 wherein the step of folding the flexible valve passageways downward includes holding the valve ends in the downward position by means of a holding tool.
 3. The method as in claim 1 wherein the step of inserting the vas valve includes turning the valve to the off position just prior to said step of inserting the valve.
 4. The method as recited in claim 1 wherein said step of securing the closed vas sides further comprises the step of inserting a flexible sleeve over the vas and the valve.
 5. The method as recited in claim 1 wherein said step of securing comprises suturing up the closed vas sides. 